title: [Method validation according to ISO 15189 and SH GTA 04: application for the detection of KRAS mutations using PCR TaqMan assay].
abstract: Since January 16(th) 2010, the French legislation requires that the medical laboratories must be accredited according to ISO 15189 standards. Thus, all medical laboratories in France must be accredited for at least part of their biological tests before the end of October 2013. Molecular biology tests are also concerned by the accreditation. Validation of molecular biology methods is made difficult, for reasons related to the methods, but also by the type of analytes that are basically rare. This article describes the validation of the qualitative detection of KRAS mutations in metastatic colorectal cancer using TaqMan PCR according to ISO 15189 and to the technical guide for accreditation in Human Health, SH-GTA-04, edited by the COFRAC.
authors.affiliation: Service de biopathologie, Institut de cancérologie de Lorraine, Vandœuvre-lès-Nancy, France, CNRS, UMR 7039 CRAN, Nancy, France, Université de Lorraine, Nancy, France.
authors.forename: Alexandre
authors.initials: A
authors.lastname: Harlé
authors.forename: Cindy
authors.initials: C
authors.lastname: Dubois
authors.forename: Marie
authors.initials: M
authors.lastname: Rouyer
authors.forename: Jean-Louis
authors.initials: JL
authors.lastname: Merlin
mesh_terms: D000068:Accreditation / Q000331:legislation & jurisprudence*; D045744:Cell Line, Tumor; D064790:Clinical Laboratory Services / Q000331:legislation & jurisprudence / Q000592:standards; D015179:Colorectal Neoplasms / Q000235:genetics / Q000473:pathology; D004252:DNA Mutational Analysis / Q000592:standards*; D005602:France; D006801:Humans; D009154:Mutation; D009362:Neoplasm Metastasis; D016133:Polymerase Chain Reaction / Q000379:methods / Q000592:standards*; D011518:Proto-Oncogene Proteins / Q000032:analysis / Q000235:genetics*; D016283:Proto-Oncogene Proteins p21(ras); D012015:Reference Standards; D012680:Sensitivity and Specificity; D013048:Specimen Handling / Q000592:standards; D018631:ras Proteins / Q000032:analysis / Q000235:genetics*
chemical_list: C117307:KRAS protein, human; D011518:Proto-Oncogene Proteins; D016283:Proto-Oncogene Proteins p21(ras); D018631:ras Proteins
keywords: ISO 15189; KRAS; PCR TaqMan; method validation